A DESICANT OUST

LONG LASTING CONTROL FOR UP Te SIX MONTHS

FOR USE IN RESID[IITS. IIISTITUTIOHS. FOOO PLAIITS. HOTElS. TlIEATERS. SCIIOOLS. TRUCK TRAILERS. BOXCARS. HOSPITALS. OFFICE BUllOIIICS ,1.140 IIOHLS

CONTROLS ANTS, COCKROACIIES, AND SILVERFISH_

ACTIVE INGREDIENTS PyiahilS ................................................................. _ ... 0.10%

'P,,",Ohyi III*Ixide. T edlnicaI ...................................... 1.00'4 Sica GeI ............................................... _ ...• _ .•....•.. __ .40.00% "INF.RT INGREDIENTS .............................................. 58.90%

100.00% *rUt,iv.,lent to O.8~ (bulylrirbilYl~(6-proP"fl­piperonyl) ether and O.ll. related compOunds.

KEEP OUT OF REACH OF CHILDREN

CAUTlON St. ,ide panel {or eddltlon.l precau­tionary .t.te~nt'.

EPA "'.g. 110., ~816-~20 E~A hI. 11..0. 279'NY-1

OkIO"E Re9istcred Trademark of ralrfleld -~neric.n Corpor.tion

,

f 11 I ~ / CODE 722.55

. ,

Insecticide • ••• • • • •• • • • • • • • • • • • • • • • • • • • • • •• • • • • • • • • • • ••• • • " • lEST AfjlU81f CO" DIRECTIONS FOR USE ISPOSAL ••••••• • •• ••• • • It Is , .. Iol.t Ion of rcdera I raw to use this

produ(,f. in <I manner inconsistent ",1th its hb.llng,

NON FOOD AREAS:

Homes. Institutions, hospit.als. oFfice buildings, warehouses, hotels, motels, theaters. scl~ls. truck traIlers, and tdilrOdd c~rs: fo control crawling insects including ants, cockroaches. sll~erfish, pilibugs, and millipedes, apply a continuous visible (. ,,.. undcrneith and behind stoyes, refrigerators, and appliances. Treat on, .,round and behind moldings. shelves, baseboards, pipe openings, cracks, crevices ind other areas where Insects May hide. 00 not use on surfaces th,a;t come Into direct contact with rood. For severe Infestations, al.ply this product behind ciblnets .nd walls, in crawl spaceS and in attics ,at the rite of 16 ounC.es per 1000 seluare feet of surface ilrea. In animal quarters, distr ibute this product ill the rate of ) ounces per 100 square feet of surface drea. Repeat trtat~ent a5 necessary.

APPLICAT IONS IIITlIllI FOOD AREAS OF FOOO HIlNOLlHC ESTllb~ISIIHEHTS:

Food processing plclnts and ~arehou5es, bakeries. Leverage Illants, restaurants, supermarkets, meat ind poultry processing plants. hotels, motels, hospitals, and schools: limited to crack and crevice tre~tment only. Using a bulbous or s'mllar duster, apply i small amount of mat~rial directly into cracks, cr~vlce\ such as expansion Joints between different elements of construction or between equipment bases ind the ftoor, wall. voids. ft'Otor hou\ing, junction boxes or switch boxes, conduits or hollow equi~nt leqs wh~re ~es. !!!..!..!.. sllv~rfish, spiders and ~..!.1 hide. tare should be taken to ~voiJ de~)sitlng the product onto exposed surfaces or introducing the LII'.lterlal Into the air. Avoid contamination of food or food processing surfices. kepe.t tre.t~nt as necessary.

A"lICIITIOHS OF TIllS PRODUCT IH T11£ rOOD AR£AS OF FOOD HANDliNG ESTA8l1SIIHEHIS, OiliER THAN AS • r .... '.In r'f~lrr TRfATllfllT Anf Ilor Pf~HITT£O

00 not reuSe eCRIJty contiine:r. and put In tr.sh collection.

IIrail cOnlC~r • ••••

PRECAUTIONARY STATEMENTS HAZARDS TlI IIUHAIIS , DOME S TIC AN IHALS

CAUTION

AYoid Inh.htior.. Containers larger than O;)e

.~--- -­---­._-- .. -

pound Intly not be used or stored in food handl ing .=:,=".,~: en.bll ....... "I •.

EIIV I ROlltl(t1T III IIlIllIRDS • Thh pro{luct is toxic to fish. Do not ap~ly directly to water. Do not OlPply where runorf is likely to occur. Do not apply when we~ther conditons favor drift frOfft areas treated. 00 pot contaminate ~ater by cleaning or equipment or dislJOsal of ",aSle5. Apply this prOdUc.t only a$ specified on this label.

Buver assumes all risks ~r use. storage or handling of this m.lteri.ll not in strict ac" cordance with directions given herewith.

.. -,._--------,

APR 81982

.......... ..,..~~~-r'. ,. ·;',·.t. '. ~' I·'· r t I '. I"f I

~i.i~'ln"" I

i:I;',:I; ia'::: ~::",:~',:.\: -"\ t. .' t' . '"1 \ ill)' ; i l r.o-;·l .,.' 'I' ~ \",.' '. ' ~ j - ' _. f·

FAIRFIELD AMERICAN COIlPonA liON 39]1 SAlT ROAD

~rc Ch~.tcal D1v1"ion Balchp. Corporation P."O.;j~ox 1aO St~ H1ll, NY 10973

" . Attention. Mary Towle

Re;ulatory co-pli.nce Coord in. tor

~bjectl SterUizing Gas 6 ftPA Regiatr.tion No. 36736~ Y~r SUb.ission ~at~1 ~qa.t 23, 1990

The labeling referred to above, .abm1tted in connection w1th regiatration ~nder the Federal Inaecticide, fungicide, ~nd R~enticld~ IIoct, .a .... ndad, ia acceptable. 1\ at."''''"Jd copy is encloaed for your recorda.

Mota to the file. The label referenced above and dated Septe~ber '", 1990 vill be the label of record and will .aperaede the label .t.~ped Octo~r 1" 198e. The la~l of Octobftr 1" 1994 should b. di.reqarded. We re~et any inconvenience the label or October 11, 1984 ... , h.ve cw.ed.

leota. Ve ha ... ho adj~ated ~r recorda reg.rding t.he new product naN for thi. product.

If you h ..... nv qa.ations concerning thia letter, con~ct Valdl. Gone.rov •• t (703) 557-3663.

Sincerely yours,

.rohn H. - ~ J7..&/ Product ~~i Anti.icrobial Proqra. Br.neh Feqietratlon Divialo" (H7505C)

~g~~~3.G.'L31-4:KENCO:09/11/90:10/11/90 CL. • R! 61 553·Y G :T 3' 4 KIRJe9 9' '13 ' I .JH.on

• 'I 1!~~fCL

~ - ::-:::::: ":':::':.:...:::: :.................. ;:;:::.. :::: ~. :~:::: ::=.. :~ ('A '_1320.1 112-7') O"ICIAL PILI! CO,"

- - - --- .-- ---

(,

I

COMPRESSED GAS '< n.o.s.

UN 1958

REG. NO. 36736-6

Active Ingredient

C 31014 N.J.l C 350114 MD-l IJ 350114 TN-1 IJ 35084-TX-1 IJ 350114 eM IJ 31iC114 PM IJ 350114 GA-l IJ 38736-NY~l

Ethylene Oxide •.••••••... 1 ~ Inert Ingredients ••••.•••••.. 88l1li TOTALCONTENTS LSS.NET Total 100l1li

Preaud..., Sb •• II .... Hmnll to Hu ... IItd DIuatIc AlII_

DANSER Extremely hazardous liquid and gas under pressure. Inhalation of gas may be fatal. Do not get in eyes, on skin, or on clothing. Ethylene Oxide is odorless. Exposure to toxic levels may occur without warning or detection by the user. PbyaIaI .. CbIIIIaIIlmrdl

DAlGER: liquid and gas under pressure. Use equipment rated for cylinder pressure. Store and use with ade· quate ventilation. Closevalve after each use and when empty. Always replace cylinder cap when not in use. Cylinder temperature should not exceed 130' F (54' C). Use in accordance with the sterilizer manufacturers operating instructions. HEAlTH MAZAIDS: Inhalation may result in delayed nausea, narcotic and possible neurotoxic effects which could lead to ernpllyseraa, bronchitis and pulmonary edema. Exposure to large concentrations causes rapid circulatory insufficiency leading to coma and death. Contact with rapidly e'!aporating lic!uids may cause frostbite or cryogenic ilurns. FIRST AID: If inhaled, remove to fresh air. If not breathing, give artificial respiration. preferable mouth-tlHIIOuth. If breathing is difficult, give Oxyge11. CAll A PHYSiCIAN IMMEDIATelY and advise him of the exposure to this gas mixture. In case of eye or skin contact, or frostbite, remove contaminated clothing and flush affected area with lukewarm water. 00 NOT USE HOT WATER.

KEEP OUT OF REACH OF CHILDREN

DANGER. ~_''''''''''''11''''i_'' In all cases of overex[llSUfe, get medical attention

Immediately, Take person to a doctor or emergency treatment facility. IIIIIIIM:Getexposed penon to fresh air. Keep warm. Make sure person can brelthe freely. If breathl~g has stopped, give artificial respiration, preferably rr,outh· to-mouth. Do not give anything by mouth to an unconscious person. n. stilt Immediately r_ve contaminated clothing, shoes, and other Items cavering skin. Wash contam­Inated skin area thoroutMy with soap and water. n iIIlJII: Hold eyelids o,en ancIliush with a steady. gentle S\reaR! of water fir at least 15 minutes.

DANGER CONTAINS ETBVLENE OXIDE AVOID BREA1BING THIS GAS

Dined....... . ..... I~ is a violation of FtderaIlaw to use this P\lOdlO:t : In a manner Inconsistertl with Its labelll",. The· product Is limited to use by medica' professiCna!c • or trained technical personnel In medical ~"d: industrial use areas. ' •

STORAGE AND DISPOSAL t f c t f , . . , I ••••

Store in cool, well-ventilated area. Avoid exposure to heat or direct sunlight. When empty, return to manufacturer only.

MlnuilClured by: ---- ARC CHEMICAL Dlv. of B.leham Corp \

P.O. Box 180

... ,.

'. The purpoae Of""e"-'9 ~ • brief. eaally understandable. non-technical dlacuulon ofttie a .ad ",~~ Ethylene Oxide Sterilization and the use of Ethylene Oxide STe batlon &e ... I>Is. • ••

It would be Impossible to~RltL&I~.wver the subject In this limited space, but we will gladly supply additional IClortl.tloD 01.Fnfer personally on speCific problems upon request. : •• : •• : : .. ......

Samples of the various ATI Ethylene Oxide sterilization indicator products rr.entioned in the booklet, and additional copies of the booklet itself, are avaiiable without cost by writing to:

ATI Deseret Medical, Inc. Parke, Davis & Company 11471 Vanowen Street (P.O. Box 9338) North Hollywood, CA 91605-6269

Introduction , The use of heat for effective sterilization has a long history. Although steam is still

the most widely employed and practiced method of sterilization, the required high temperature and moisture can damage certain materials. Many items made of plastic, rubber and metal can not tolerate exposure to the high temperatures of 250°F. (121°C.) and 270°F. (132°C.). This problem led to the development of a sterilizing agent: gaseous ethylene oxide. It proved to have a high penetrating ability and could be used at ambient temperatures. The wide-spread use of ethylene oxide today is based on its ability to destroy microorganisms, such as bacteria and viruses, without damaging sensitive materials. Ethylene oxide Is not a substitute for steam sterilization, but la an alternative method for temperature-sensitive items.

IMPORTANCE OF STERILIZATION DefinItion

The terms sterile, sterilize and 3terilization are only accurate when there is the absence andlor destruction of all microorganisms. This includes bacteria, their spores, fungi and viruses. The process of sterilization must destroy all microorganisms, including those which cause disease or infection (pathogens). There can be no compromise In the use of these terms. An object Is either aterlle or nt't sterile. There Is no .uch thing •• "almost" or "partially .terlle."

Role of Infection Control The increasing problem of hospital·related infections (nosocomial infections) has

focused attention on the vital importance of correct sterilization procedures. Modern hospitals have Infection Control Committees, which both monitor and assure item sterilization procedures. Joint Commission on Accreditation of Hospitals (JCAH) guidelines state that • ... There shall be an effective infection control program within the hospital.· These guidelines affect numerous hospital departments (Central Service, Operating Room, Emergency Room, Obstetric Service, Inhalation Therapy, etc.).

The Central Service Department has an impo.1ant role in the decontamination, proceSSing. packaging and storage of Ilems which require sterilization. The success of any infection control program ultimately lies with well-trained CS and other technicians who have the daily responsibility of assuring sterilization quality control.

,_.------2

. . '

The JCAH hu rec:ommended ~ ....... ~ In J*! •• foIowa: ... .. ...... . • •• •• •• • • The ... haU be wrlUen poIIcIea antL 'Pro"""" ro..fh'-Ctecont.mlnatlon and

sterUIz.tlon actIvItl .. performed In central MlVIcae .nd elsewhere In hospital. and for related requirements. Thue pole'" .nd P'P'iIP". IIgJId relate. but ... not limited. to the following: :.. : :: : • ••• • ••• • • ••

• The receiving. decont.mln.tlon. ett •• lllng.· pfeparlng •. d'.'nfect'ng. and sterilizing of reusable Itema.

• The .... mbIy. wrapping. storage. distribution. and quality control of sterUe equipment and maclcal supplies.

• The ::se of sterilization proceaa monitors. including temperature and preaaure recordings. and the use and frequency of appropriate chemical indicator and bacteriological spore teats for all .teriAz ....

• Designation of the sheH lfe for each hoapItaI·wr ....... nct-.terUIzed medical Item a,ld, to the maximum degree possible. for each commerclally·prepared Hem, by a specific expiration date that aeta a limit on the number of days an Hem will be considered safe for use. Where posaIbie. load control nUlllbers should be used to designate the hospital sterilization equipment used Item, including the sterilization date and cycle.

• The recall and disposal or reprocessing of out-dated sterile supplies. • SpecIfic aeration requirements for each category of gas·sterllized Items to

eliminate the hazard of toxic residues. Chemical Indicators should be used with each package sterilized as required. The use of other sterilization monitors should be defined. In ioads undergoing gas sterilization. a Ave spore control should be used at least weekly and Is recommended for Incorporation Into each sterilizing cycle. When Implantable or Intra-vascular material undergoes gas sterilization, live spore controls should be used with each load. Where feasible, the results of the spore test should be ascertained prior to use of gas-sterilized items.

Sterilization Methods Scientific sterUlzation is less than 200 years old. In Its earliest stages, dry heat

was the primary method. and is stili used for certain materials (e.g •• powders). Later, in the 19th century. steam sterilization techniques evolved. Even today, steam sterilization Is unquestionably the most effective and economical method of microorganisms destruction. However, heat·sensitlve materials are not wl·lI-sulted ·for this method. .!oi .'

!~, .\. The introduction of ethylene oxide's sterilizing ability overcame the problerjlS cJf

materlsl damage by heat. The Division of Hospital and Medical FacilltlH of the u. s. Public Health Service recommends that steam under pressure, dry heat and ethylene oxide be the main sterilization methods used by hospital faclHtles. Other commercial methods now in use include the high-energy electron beam and gamma radiation.

The Army Chemical Corpe was responsible for the development of the ethylene oxide gas sterilization proceaa • used In hospitals. They sought and found • beaerlcldal and sporicidal gas that was effective at lower temperatures. penetrated porous aubatance. •• nd did not corrode or damage metal. paper, plastic. rubber. Ie.ther, wood or wool. It was also required that the gas be easily removed by aeration. ac:I rapidly, store easily. have low human toxicity. be non·flammable. eully·handed and readily av.iIabIe. The problem of pure ethylene oxide'. extreme flammability and explos/vlty was overcome ~ mixing It with .n Inert gas IUCh • carbon dioxide or Freon •

;. •

. .

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PRINClPLI8;OP.~~I¥TION llactellll, IpOlM • ..' • ••• -I-

Baclerta, their 4Md vtuIIt ~. rfteIor cause of infection and eIIIe .... Bacteria and vlrus.s are capable of reproducing by the mlUlona .t very rapid rat.s. Bacteria exlat In wh.t Is temw! aII.~e or vegetative state, reproducing .t regular Interv.la. They are' also ~or~.1 under extremely adverse conditions by going Into • protected dormaOn .... :'inoWi as • spore. These ~ can aulVlve for extended perIoda, even undIr ~", he.t, cold or deaIccatIOn which would kill vegetative bacteria. Spores become active when agaI(I placed In a ta.oIabie environment. It Is for' this reason that sterilization must be .n absolutl! process, with complete pathogen destruction.

Certain surgically-critical bact.rla (notably anthrax and clostridium) can sever.1y complicate the health of ;: hospitalized patient If not destroyed. For .xampl., .al)yl surgical Instrum.nt that has only a few surviving bact.ria or spores could become (llifIltly contaminated, due to the rapid reproduction of the bact.rla. An operative wound

.• ~sed to these pathogens could result In delayed patient recovery, Infection, and even . (jaath. The lethal effects of ethylene oxide on bacteria, spores, viruses and fungi have been .xperlmentally established. The precise mechanism of action Is stH! uncertain. However, It Is thought that the gas penetrates the microorganisms and chemically reacts with Its prot.lns. This process disrupts the life functions (metabolism, reptoduction) so that the cel can no longer sulVlve.

Crltlca' Varlablea Ethylene oxide sterilization Is a complex process. In order for It to be an effective

sterilizing agent, there must be the proper relationship between the gas concentration, moisture, time and temperature. Alteration of anyone of these four variables can affect the oth.rs and change the sterilization process. Though these conditions usually vary based on the specifications of different sterilizer manufacturers, the basic principles can be outlined as follows:

Ga. Concentration: In Its pressurized container, ethylene oxide is a liquid and must be vaporized to effectively permeate and sterilize the load. Pur. ethylen. oxide gas is extremely .xplosiv., flammable and toxic. It is. ther.for •• often mixed with en Inert (188 to be r.ndered non-flammabl.. Gas concentration is m.asured In mUligrams per lit.r (mglL) of chamber spac •. This can be mathematically calculated (If needed) by using readings from the sterilizer pressure gauge. The range of effectlv. concentrations Is usually 450 mglL to 1500 mglL Th. higher concentrations usually result In a short.r st.rlllzation tim.. This however, Is based on chamber t.mperature, and oth.r factors. The sterilizer manufacturer'. In.tructlon should be carefully followed.

Molature .nd Humldlly: Moisture is measur.d in terms of relative humidity. This Is the ratio of the amount of wat.r actually present in the air to the greatest .mount the air can hold at the same t.mperatur.. Ethylen. oxide gas II generally considered a dIy sterilization process. However, water vapor must be pres.nt, but not at the saturated (1 ()()')(. relatlv. humidity) leve' of steam sterilization. The relative humidity should be at least 30%. Too much moisture, howeyer, can cause the formation of ethylen. glycol. This Is a toxic compound which can remain ss • rea/cl.le In sterilized Items and slow the lethal action of ethyl.ne oxide. Dry cella and spores are much more resistant to ett,yIene oxide st.rlllzation. WIth some sterilizers the racommended procedure Is to "pre-condltlon" the load bJ dowIng the chamber to be filled with a hlgh-

.'

, , } . ~ ,

,.

humility abl""" far at ...... 3q."'""'" ............ IUfface of the apcna and. lllua. aiel .. ,.I.rttlld:::rJ:::;hlbfd, Ii ..... oxide. Willi olher aterlllzera. moIaIure Is lidded ":cyde~. I" theorized thai the waler -carrle,- th. .Ihylene oxide inlo the microorganism. where It can chemically react. Oloae .ttention m"J_W _ ~poper humidification. It II probably the moal common cauae of M-• .,...,SIn baa-sterilized llema. · ... ···f .. • • W TI .... : e...". ...... can Yrf gr • .., .. -n.t. .. ~ NCh !oed .. .rtacAwd by lhe r .... lv. contamination. denaIIy. contents and permeabllhy to .thylene oxide gas. Aa. reault. the sterllzatlon lime muaI be actuated accordingly. Th • • t.rlllz.r manuf.ctur.r·. In.tructlon. Ihould b. c.r.fully follo •• d.

T.mp.r.tur.: Elhylene oxide vaporlz" (from liquid 10 gas) at 5OOF. (10.5°C.). II can. therefore. be an effecllve sterllzlng agenl at temperatures as low as 7ooF. (21°0.). Higher lemperatures. however. allow shorter cycles by enhancing the gas diffusion rete. The usual operating lemperature for ethylene oxide sterilizers varies from 70-F. (21°C.) to 140°F. (60°0.). Temperature also affects the pressure of the gas. If the temperature drops after filling. It would cause a reduction In the gas diffusion rate. A preheated chamber will allow the gas to stay In a gaseous state. Careful attention must be paid to the chamber temperature and gas pressure.

Of the four critical variables essential to EO gas sterilization. only .xpolur. time can be accurately measured by the technician. Gas concentration Is dependent on how it Is supplied and Injected Into the sterilizer. Temperature Is usually read at only one point. and Is not Indicative of temperature in various parts of the load. In most sterilizers, moisture Is not measured. A change In any one of these variables changes the other three. Therefore, .lw.YI follow the expo.ure condltlonl I.t by the sterilizer manuf.cturer.

L1mlt.tlonl Ethylene oxide has provided the health care industry with an important

sterilization method for those materials which are adversely affected by steam or dry heat sterilization. Nevertheless. this method has some limitations. Ethylene oxide sterilization Is a slow process (much slower than steam). It also requires relatively expensive equipment and a sidled operator. Some other common problems Include: ::.

1) the necessity to continually monitor temperature, gas concentration and~~i . humidity on a manual sterilizer. ; I~-J

2) the weakening of and'or surface damage to oertaln acrylic and polystyre~- ~ Items, the crazing of some Instrument lenses an~ dissolving of lens cement.

3 ) the formation of toxic compound by-products. 4 ) the retarding of gas penetration by protein matter and soli. S ) the Inability to sterUlze solution'.

MOlt Import.ntly. r.cent r •••• rch Indlcat.. th.t .xpo.ure to .thy..... oxide II InJurlou. to human.. The.. health-related problems win be dlscu888d In delaH (See page 10; Precautionary Meuurea UsIng Ethylene OxIde).

PRACTICE OF ETHYLENE OXIDE STERILIZATION St.rlllzing Equlp .... nt

YarJoua kJnda of .thylene oxide aterRlI.,. .,. In uae today. TheM Include fully automatic. Mml-autornatlo and manual con_ .,.aeme. They range In .Ize from ......

5

" '~. '" ' -"" " ,. .": -:

t .... top·,n;om·1e~_ me,ele 4t .... ~·automatlc built-in units. The following· dlscI .. lona til w.;,.'ct'i ..... i ..... ·top model to the fully-automatic unit: -.- -.. .. •• : -.

Tabl .. Top Room Temperature lIodei These ~Int!\fIned for aterlllzing small objects. They

operate for a a .... ~Ethe ambient room temperature and humidty. In order to ~ .. t the lower room temperature and humlclty • ..., NeJlIred a1llgfler ala_ ,,,'Ion and the IddMIon of meillure. Because of the hazardous nature of ethylene oxide, a sterlizer should naver vent dleetly Into a room as some oId-atyie table-top models do.

Automatic lIodaie A variety of models and operatIOnal procedures exist for th .. e aterlllzers.

Some models Incorporate the Injection of ateam Into the sterilizing chamber . •. • :~hls allows more rapid sterilization, because the materials are heated and tialimolstened by the steam .

• :~ After sterilization, the ethylene oxide gas Is evacuated from the chamber and replaced with filtered air. The load Is then removed for aeration. In general, a cyde consists of: conditioning (pre-humidification), gas charging, sterilization p"riod, vacuum phase and filtered air replacement.

Sterilizing Procedure. Always follow the sterilizer manufacturer's operating procedures. The most

commonly used steps of operation incorporate the foIowing procedures: 1) Preparation: Materials should be surgically clean, free from soli or

protein matter (e.g., blood tissue, or fluids), nlust be towel-dry, and free from water droplets to minimize the formation of ethylene glycol. All caps, plugs, valves should be removed to allow gas penetration. Needles and tubing should be open at both ends. Syringes should be disassembled.

2) Loading: Load similar to steam sterilizer. Gas should be allowed to circulate freely. Avoid ovefloadlng and dense packs.

3) Temperature: Pre-heat to operating temperature. This speeds up the lethal effect of gas.

4) Firat Vacuum: Draw a vllCUum. Drawing time varies with chamber size. RapId reduction of pressure within the chamber can cause bursting of sealed bags. Wrapping materials should 'breathe" and adjust to change.

S ) lIoletura: A minimum relative humlJity of 30% Is needed for standard gas sterilization cyclea. Some aterillzer models require the addition of water or wet spong .. to supply minimum moisture required. Automatic models Inject moisture Into the chamber to maintain the proper relative humidity. A conditioning period vf 30-60 minutes should follow moisture Injection. This time allows for humidification of dry bacterial spores and thus permits rapid lethal action of gas. Some chemical Indicators have been developed to reflect insufficient moisture.

6) Gae In)actlon: Recommendations concerning ethylene oxide pressure and concentration vary with aterlllzer: follow manufacturer's Instructions. Some sterilizers do not allow expansion and preheating prior to chamber entry. Preheating the g .. elimlnatea expansion cooling effects and condensation of gas Into liquid (which can cause material damage). Ethylene oxide/carbon dioxide mlxtur .. tend to stratify In large atorage cylinders due to their dfferent atomic weights. Therefore, under certain condltlona, the final 20% of the remaining cyHnder contents may not contain sufficient ethylene oxide to be • sterilizing agent. Ethylene oxldelFreon mixtures r.voId this problem.

8

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•

7) EKpoeU,. Time: II 1e~~.lIve·JO·~.e: _Iz.,. for the time recommended In the ~""e Jlli1JSi:tlOn8~: : :

8) SICO'. Vecuum: AI end of ... IH lime, e1fty1elfe oxide Ie removed from chamber by drawing a second vacuum.

9) Atmoepherlc R .. toratlon: Aa..-doel ~6.IIIt.red air Ie admitted to chamber 10 re.tor. almosphe2~eJ .. PI.rUlzer door ehould be opened and Inhalallon 01 any pM IIJU8& be avoided. ItemI ehouId not be removed for at ..... 5

1 0) Aeration: Items must be property .... ed to remove residual g.IS. (For detaMed dIscc •• Ion, ... below: Aeration).

ADVANTAGES AND DISADVANTAGES AI previously discussed, the main advantage of .thylene oxlcie st.rIIlzatlon Is lis

ability 10 sler81ze those Items which .... adv .... 1y affected by sleam or dry heat. Although .Ihylene oxide has the pol.ntlal to Slerlllz. mosl hospital Items, a number of disadvantages limit Its us.. These Include toxicity to personnel, higher costs, longer exposure and aeration tlroo. II Is not recornrnended lhal ethylene o::1de replace steam or dry heal slerlHzallon when the laner methods are applicable. Bul availability of all three methods offer a complete sterilization system tor every hospital.

Ethylene oxide can be used to sl.rIIlze plastics, rubber, metal, leather, wood, wool, rayons, nylon, glass and virtually every other material. Table 1 shows the more commonly used articles which are compatible with ethylene oxide sterilization. Pure ethylens oxide does not cause damage to mos' :naterials. However, it can have adverse effects on some items when it is diluted with Freon (S88 Precautionary Measures).

Insttuments and Equipment • Cautery Sets • Dental Instruments • Eye Knives • Lamps • Needles

• Neurosurgical Instruments • Scalpel Blades • Speculae • Lensed Instruments • Mlcroslllgery Instruments

Plastic Goods • Catheters • lIeart Pacemakers • Infant Incubators • NebuHzers

• TestTubes • V~ • PnNdhesls • I~ants

Rubber Goods • Catheters • Drain and Feed Sets • Sheeting • Tubing • Respiratory Tubee: .

~~ .... T.I.scoplc Instrum.nts !p.?

• Bronchoecopes • Cystoscopes • ArthI'06alpeS • Endoscopes • Esophagos¢opes • Opthalmoscopes • Otoscopes • Pharyngoscopes • Proctoscopes • Resectoscopes • Slgmoldoeoopes • Thoracoscopes • Urethroscopes

Mllc.lllneous • Blankets • Books • DUators • Electric Corda • Hair Clippers • Medicine Droppers

• Mlller·Abbon Tubes •. Motors • Ponery • Pumps • Sealed Ampules • Toys

AERATION Although sthylene oxide gas provides an .ffectlv. method of sterlHzallon for heat

and molstur.· .. nsltlve products, .xClsslve residual amounts of EO or Its by-products (.Ihylen. glycol and ethyl.ne chlorohydrln) may be harmful to pallents and hospital personnel. Exposur. to Iteml IUCh .. prosth.tlc devlc .. , surgical Instruments, cathetsra, etc., which have not been praparty aerated ,'msquent to IIerIIzatIon could

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•• ••• • ••• Medical devices. ~W ....... Ized before marketing •• e uaualy free of

any harmful levels of r.ldual,:qorll IJ¥1Joduc* by fie time fIey ruch fie hoIpItaI.

Suggested aeration limes .... follows: Recommended Mratlon

Product TImI All mater IaIs aerated at room temperature . • . • • . • . • • . • 7 days All materials aerated In an aeralOr .•..•• , •••• . •. • • •. 8-12 hIS. at 122°F.(SO°C.)

. to 140·F.(60°C.) ·ilj(Req.,.at apeclflc Inatructlons from the a.rator manufactur.r)

. !f,:, AI sterilized Items should be sterid In a wen-ventilated area which protects them from extremes of temperature and humidity.

ROLE OF WRAPPING MATERIALS Introduction

The use of ethylene oxide as a sterilant has enabled the marketing of· many new pre-sterRlzod plastic hospital articles. These hems were previously not avallat.;e due to the manufacturer's inability to sterilize many types of ."3Stles. This development has created a need for special packaging materials in which such a product can be sterilized and safely stored until used. Similar types of packaging materials are also available to hospitals.

Muslin wrappers, non-woven paper wrappers, and paper bags are acceptable as ethylene oxide wrapping materials. They are limited, however, by the lack of visility and high porosity. Transparent pouches and tubing are preferable because they allow the user easy identification of the contents.

Not all packaging materials are acceptable for ethylene oxide sterilization. A greal deal of teatlng Is often nllC8SS8ry to determine which materials. or combinations of materiala. Ia satisfactory. Wrapping materials not to be used because of inadequate permeability Include:

1) Nylon tim 2) Foil 3) Saran 4) PoIyvinyIchIoride (PVC) film Avoid combinations of materials which make a non-penneabie paclulge .'nce gas

penetration to the product Is essential.

An acceptable ethylene oxide wrapping material must meet the folloWing requirements:

• Readily available In a variety of 1Izes. • Permeable 10 ethylene oxide gas and water vapor. • Must allow air inside the package 10 eteapIt 10 that the package wit not burst

durtng the VllCUum cycle. • Must protect sterile Items from recontamination during storage.

If you are uncertain .. to the suitability of • partlcular packeglng material, you should concact the manufacturer of the material for Information and guidance concemlng the appoprIate EO sterilization and Hra1Ion p!OCtdureI to be used.

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--------------------~-------- ---Before ualng • new padcaglng J'I."", ll .. ft6IIld .... tt=. In the .terlllzer In

which It will run. Biological IndIca",,"!IhauW°be° ~ the m.t~rlal and sterilized according to 1nstruCt1ona. The ttebg~ .. nillcatorrshollid then be cuhured. If the resuhs are negative (no growth), the packaging material Is sa~ to use.

•••• ••• •• , U • 0..· Procedure. or .. ••• • •• : Wher .... team tendllo delcend = ,,·!:t:it sterilizer, ethylene oxide gas

dIffus .. In all cIrectIona. Therefore, the • o't Met packliges Is not .. critical when using ethylene oxide gas. Nevertheless, care should be taken not to overlof. d the sterilizer. Compression of plastic-wrapped packs against one another will hinder the evacuation of air. This may Increase the chance of having the packages burst open when the chamber pressure decreases es the vacuum "drawn. Compression of the packages may also prevent sufficient penetration of etlr/lene oxide gas. To reduce the possibility of bursting, remove most of the air from the package before sealing. If bursting still occurs, contact the manufacturer of the packaging material for special l'lstructlons to eliminate this problem. Materials which protect items from recontamination during storage Inherently have a low air permeability and therefore, have more of a tendency to burst during vacuum cycles. Not all avaHabie materials are acceptable for every type of sterilizer; what may be adequate In one will sometimes be unsatisfactory In another.

A recommended procedure is to place a chemical sterilization indicator (such as an A~I STERILOMETER-PLUSlEO or an ATI ETHYLENE OXIDE STERIUZATION INDICATOR) inside each sealed package. These provide immediate visual evidence that sufficient sterilization conditions are met Inside the packages. It is also r~mended that a biological sterlHzation Indicator (such as an ATI SPORE-O-CHEX) be used with each load.

ATI Pouche •• nd Tubing ATI Pouches and Tubing were developed to permit the penetration of ethylene oxide

gas and moisture. They are available in a variety of sizes, and have an ethylene oxide indicator printed on them.

They can be used In all ethylene sterilizers. Each has an Indicator which changes color from yellow to rust/red during ethylene oxide gas sterilization.

Storage Life The storage life of any sterilized Item depends on a number of factors: 1) type and unllormlty of wrap packaging material. ~~. 2) storage conditions (open or closed shelves, frequency of handling, cleandie'ss

of the storage area, use of dust covers). ' . 3) atmospheric conditions (temperature, humidity).

Numerous studies have been conducted on the sheH Ufe of In-hospital sterilized items (packs and packages), but the test results apply only to the materials and storage conditions under which the tests were conducted.

Sterile shelf life must be considered an event-related condition (such as factors, 1, 2, and 3 described above) rather than only a time-related condition.

However, since the number of the event-related conditions prohibits setting reasonable event-related guideline, the following tlme-rel.ted shelf IHe limits suggest some guidelines which may be used as a starting point for further investigation:

muslin, non-woven fabric and paper

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plastic pouchee (fteai"IIed)~ .• ~, ...... -........... .. any of the eove ImmedateIy placed

21 to 30 dIya 21 to 30 daya

6 months

Inside of a heat· .... ad cNat 001/., _... . . . . . . . 6 montha It Is recommended ttui" ~""'erlllzad materials be used wllhlr. a 48 hour

period. If thla Is not ~Iije •• "'1 ..t. .... wrappIng with a duat cover should be ~ad. IOn

STERILIZATION INDICATORS The preceding IOpIca have shown that a nllmber of Important variables must

interact In order 10 assure ethylene oxide sterilization. The materials must be exposed to a specifIC gas concentration which Is crilically dependent on the integrated effect of hu~ity, temper3ture and time. On most sterlllzera, recorders and gauges indicate '.rature and pressure conditions In the chamber. However, they do not monitor the _itions within the packs .

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The use of certain types of ethylene oxide sterilization Indlcalors placed inside the pack wll show whether or not sterilizing c:ondit:ons have been met. These indicators will monitor all four of the essential elements for gas sterilization. There are several types of indcators available for hospital use.

Biological Sterlllution Indicator. The JCAH urges the use of a live bacterial spore test at least weekly and

recommends their use In each gas sterilizing cycle. Their effectiveness Is based on the theory that if sterilizer conditions are sufficient to kill the specified spores, then nothing else will survive. The resistant spores of Baclliua .ubtlll. (niger) are the most commonly used organisms for monitoring ethylene oxide sterilization. Although these biological tests are an integral part of quality control, they do have practice limitations:

Delayed R.ault.: Test results are usuany not available for at least 24 hours (and up to 7 days). This makes II Impractical to quarantine all goods for that length of time. Statl.tlcal Sampling Problema: The number and frequency of tests required 10 assure detection of sterilizer failure Is not economically feasible. Many more testa would be required 10 obtain a sate statistical level of confidence. Fala. Posltlv .. : Culturing technique Is important so as to avoid contamination of the test which would cause growth from a foreign organism. As a result, a certain number of tests give false positives. Lack of Standtlrdlzatlon: Many commerclally·avaHable spore preparations appear to show variations in resistance. This may occur In different iots from the same manufacturer.

However, biological sterilization Indlcatora represent an Important method of monitoring sterilization for Infection control.

ATI Dlaposable EO Ga. Biological Teat Pack The recommended method for teatlng an ethylene oxide cycle wtth biologicals la to

place the biological indicator Inside a syringe whose tip Is open but wtth the rest of the barrel cIoeed. This syringe Is wrapped In a towel tnt placed In a pllperlfllm pouch. The pouch Is placed In the sterilizer wtth the rest of the load.

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ATI Spor.o-C"ex. :., : •• ' ! •• : For IlION hoIpM." wishing 10 INke .",6eII& own:..a PIICkag", .". ..,. ate

avalabll. AT! Spore-O-Chex contain both ...... rolhermophllu. lor ... tlng atHIII cycles and 8. aubtllia (nIGer) for teallng ethylene oxide and dry heat cycles. The live spores of B. subtllls (niger) which survive at 15 minute. In 600 mglL of ethylene oxide at 130°F.(54°C.) and at le .. t 30% relative humidity are killed after 120 minutes of direct exposure to these conditions. As previously atated, JCAH recommenda the use of a live bacterial spore teat. .

Each Spore-O-Chex Biological Sterilization Indicator test set consists of an envelope with 2 teat strips on one side and a control strip on the other. Simple and specific Instructlona to the Supervisor and the Bacteriologist are printed on the envelope. There Is also apace to record the teat data and results. Spore-O-Chex atrIpa are also available In buk.

There are other methods available, chemical indicators for example, that offer the practical advantage of Immediate results and the economy of use in each pack.

Chemical Indicators The JCAH recommends that chemical indicators be used with each package

sterilized. A chemical indicator is a chemical system which, by a visible change, indicates that certain chemical andlor physical conditions have occurred. These indicators are available In various forms. Some react only when exposed to ethylene oxide gas. These are considered "processing Indicators". Others react when exposed to sufficient gas concentration, moisture, lime and temperature required for ethylene oxide sterilizing conditions. This latter type are "sterilization Indicators". However, both forms offer a simple and economical method of checking each load and every pack or package.

Ethylene Oxide Indlc.tor Tape Ethylene oxide sterilization does not char'l18 the appearance of packs or packaging.

II is, therefore, desirable to differentiate between processed and unprocessed objects.~ means of ldentlflcallon tape used 10 seal the packs. The Indicator on the ethylene qlfIii tape changea color when exposed 10 ethylene oxide gas. This provides visual evidence"" a pack has been processed. It does not, however, verify sterilization of the contents.!'

ATI St .. m and Gas Labels These are pressure-sensitive labels with chemical Indicators. They can be affixed

to any package or article being sterilized. The EO gas chemical Indicator changes color from yellow to ruat/red when exposed to ethylene oxide gas. A complete failure to roJact Indicates no exposure to ethylene oxide gas. This label provides an Immediate visual Indication an article has been processed through a sterllzer.

ATI Sterllome'er-Plus®/EO Sterilization Indicators A lack of proper humidification Is probably the single most common maHunctlon

occurring In hoepItal EO sterilizers. Without adequate humidity, the ethylene oxide has dlfflcuhy penetrating the cell wal of the spores and Ita effectiveness Is greatly reduced. ,

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I BUT AVAILlB,lE COPT J

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-,' -,' • ·'TM ATI.81 ........... Plf!oEG II ... indicator designed to relay • much

information • ~ PII ~~fehollurlng • lIeriIIH .. , IncIucIna the pr ... noe of .tequaw. ~re. :TJW S~ter·PlullEO Ie • Plll)er IIrIp IncIcator with two lndlclltor epota. Both apota .re InHiaIy orange: when expoled In • property functioning llerIIIzer .nd run th!O"ih a normal cycle, the left IPGt tun .. brown to lhow expolUre to EO gu, and tilt ~'"' lfot1Ch green to 1ndIcat. that the atmoaphere was properly humidified and the PWrCt4fMel!d temperature conditio ... re met. If any of the four ...... tIaI parame"" nee ... L, for EO llertllzatlon .re not pr ... nt, the Sterilometer-PlualEO shows It Immeclately. In IIddItlon, Sterilometer-PlualEO Is covered with a clear plastic overlay, preventing the IndIc'ator Ink from coming In contact with items being sterilized.

ATI Ethyl.ne Oxld. St.rlllzation Indicators The .. are paper strips with a chemical Indicator bar which changes color from

YJlI~ to blue when all 'our conditions for EO gas sterilization (sterillza:lon time, EO g,.poncentratlon, moisture and temperature) have been obtained. They should be used

. ~ a pack or package.

The ATI Ethylene Oxide Indicator changes color from yellow to blue In 30 to 45 minutes when exposed to at least 30% relative humldHy in t40°F. at 600 rngIL. At less than 30% relative humidity, the indicator will require addhional time to change color. A partial color change to yellowish green or to a green color indicates that the rflQuired sterilization condhlons may not have been met.

Important Not. When the ATI Ethylene Oxide Indicators fall to react, h Is often due to the fact that

some sterilizers depend upon the humidity in the air for moisture. This may be insufficient for sterilization. To overcome this lack of moisture, some sterilizer manufacturers recommend that a small sponge or gauze pad saturated with water be placed on the bottom of the sterilizer at the rear. The use of a ·condhlonlng cycle· (as outlined on page 4) is also a recommended procedure for overcoming this lack of moisture.

ATI Product Performance All ATI Sterilization Indicators meet rigid quality control specifications before

being released for sale. These specifications are available from ATI upon request. Random samples of every ATI SterUlzatlon Indicator production lot are tested by an independent clinical laboratory against a standard biological control. All ATI SterlHzatlon Indicators meet (or exceed) the parforma,1ce spaclflcatlons of the biological Indicators, and copies of the laboratory report are available for any lot on request. Each indicator strip carries a lot number, by which the history of the product can be traced. Figure 1 shows the performance characteristics of the ATI Ethylene Oxide Sterilization Indicator.

12

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• - .,. ., I', PRECAunONARY MEASURES IN _riG-srAJlpiE~, : . .. .. , . . .. - .... ... The Effect 0' Ethyl.... Oxide Expoaure on Pereonnel

It.; I 17

It Is well known thet ethylene oxide Is a atro."Jlo. ~ffectlve sterllanL Common sense tells us that If It can destroy mlcroorganlantt:ft PfJ~:harmful to other living things as well. Usera of ethylene oxide haYelong bf!'t CIflIlDntd"P be careful when In .... that could be potentl-' expoaure ..... buI only .. _the ~.,.. ye .. have the effecta of ethylene oxide on hum_ been studied. and these atud' •• ahow that expoaure 10 EO should be severely limited.

The primary group responsible for establishing guidelines to ensure a safe environment for workers Is the Occupational Safety and Health AdmInlstretlon (OSHA). In late 1984. OSHA published ... t of regulations stating exactly the Hmlta of worker exposure to EO and how these exposur.. were to be monitored. Essentially. the Permissible Exposure Umlt (PEL) Is 1.0 part per million based on an a·hour Time Weighted Average (TWA).

In order to determine the current worker expoeure levels. hospitals were required to perform Initial monitoring on all potentially exposed personnel by February 21. 1985. If this Initial monitoring shows that exposures exceeded the PEL, the hospitals are required to reduce EO In the air. Also. monitoring must be repeated frequently to be sure EO levels are not Increasing. Furthermore. a program of medical surveillance must be established to see If the personnel are showing any III effects from their exposure. and personnel must be educated about the potential hazards of EO exposure.

If the monitoring shows EO concentrations below the PEL of 1.0 ppm but above 0.5 ppm equipment modifications are not necessary but medical survelDance and education programs must stili be continued. as wen as periodic remonltoring to be sure EO levels have not Increased.

If the exposure levels are below 0.5 ppm. fewer steps must be taken. Medical surveillance and remonltorlng need not be done unless there Is a change of equipment or procedures that might caloSe EO levels to Increase significantly.

These regulations are designed 10 accomplish three things: 10 determine the extent of exposure of workers to ethylene oxide. to limit that exposure to a safe level. atld for the employers and workers to be Informed as 10 eff8CII of EO exposure. i:· .

Ir." ATI EO Monitor ,'. : .•

The ATI EO Monitor Is an analytical sampling device wt.ich can accurately measure ethylene oxide down to less than 0.1 ppm In air. The devlce's chromatographic absorption sampling method combined with the thermal desorption and gas chroma~raphic method of analysis have an accuracy level of ±20.8%. The device can be used as a passive sampling monitor or can be attached to a personal sampling pump for use In the active mode.

The top (yellow) end cap Is removed and dIecatdecI •• Iowlng diffusion to begin. 1he other end cap (red) should not be removed. When aampllng Is finished. the top end cap Is replaced to prevent further diffusion taking place. A replacement end cap (red In co!or) Is provided 10 show that the monitor has been used. The exposure time must be carefully noted. The conc:ept of passive sampling Is 10 measure EO levels over an extended period of time. usually eight hours. buI not I ... than 30 P'inutH. For shorter term "mpIIng. the monitor can be UMd In lICIIve mode .. dB. "Ibed neaL

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Duttna eeL""~ a ..,.~ of air .. ~ through the ... UIIng a callnted a.npIIng ~~.s.....,.. ..... _gf~ mVmln. are reoonvnencW. Active sampling I. Ideal for~~·term:""u~eme .. urements (1()'30 mlnutn). Tube saturation occur. when an excesa of 50 mg of EO Is trapped.

The ATI EO Monitor fuIIitC .. "Ol tFifequJrements for ethylene oxide monitors set forth In Tille 29 part 1019 of fltDSK4 ~. •• ••••• SAFETY REQUIREMENTS

Sterilization and a.,atlon equipment .hould be: • In.talled correctly (In consultation with the manufacturer). • Placed properly (In well ventilated areas). • LOCIIIM remotely (not adjacent to work areas where employees are

0' •• 1 normally required to be stationed). ~j~ Maintained Requately (by a preventative maintenance program).

!:'" • Studied for modification (to provide a local exhaust feature near the door of the steriUzer H appropriate).

• Con.l4tere:t for replacement (as newer designed and more efllclent equipment becomes available). .

Employ ... • work environment .hould be: • Well ventilated. • Away from .terlllzer •• • Monitored periodically (to determine employees' exposure to ethylene

oxide).

Employ... .hould be: • Carefully tr.lned (In the proper methods for unloading sterilizers and

Ioadng aeration cabinets). • Constantly aware (that Impro.,er procedures can expose both the operator

and other employees to ethylene oxide unnecessarily).

SAFETY

Only Sterilize With Ethylene Oxide When An Alternate Method (Steam, Dry Hut) Doe. Not Exl.t

o For sterlAzIng In Its pure torn, pure ethylene oxide gas Is extremely flammable. exercise caution.

• Locate sterRlzers In a restricted area to limit unauthorized access. o Locate sterilizers In a room that has between 6 and 10 air changes per hour. • Always vent sterilizer exhauII to the out.lde. • After a complete cycle. open door with caution and do not remove articles for

5 minutes; leave a de. 10 foot radius around sterilizer. • Venl aerator exhaust to the out.lde. o Keep records of sterilizer malfunction and repairs. o Store tanks In special areas to meet bulkllng codes and temperature

~Jons; tanks should be chained to an adequate support.

HEALTH o Avoid breathing ethylene oxide vapors. o Avoid direct skin contact. • Use protective gloves to take Items out of sterilizer.

14

81'1

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------ ---------------~---------Minimize handling of aterlllz4Jcf ilacns. > '. u; • '. .'. ... -.-.

• Report any accIdenta or pro~ .. xposdr8lo ~. Pull, don't push, loaded carts to IIW aertMr; •••

• •

MATERIAL DAMAGE •••• ••••• . • Freon-diluted ethylene oxide can ~ cta~ t' certain plastic tnaterials

including: Tenite, Styron, Lucite, lt1d P.tH\gIM.·; • Can cause crazing of some plastic Jell'" lind dUorve some lens glues.

SUMMARY CHECK LIST

Sterilization Principles • Three main methods: steam, ethylene oxide, dry heat. • Must kill all microorganisms (bacteria, spores, viruses, fungi). • Critical ethylene oxide variables:

1 . Gas concentration: 450-1500 mg/L 2. Temperature: 70·F. (21·C.) to 140·F. (60·C.) 3. Relative humidity: 30% minimum. 4. Total cycle time: 2 to 12 hours depending upon the other three

variables.

Practice of Ethylene Oxide Sterilization • General Processing Procedures;

ALWAYS FOLLOW MANUFACTURER'S INSTRUCTIONS • Models: Table top - operate with caution· do not vent toxic gas into

room. AutomatiC. Semi-Automatic. • Wrapping materials: Several types are commercially availabie. Select

with care as each material has advantages and limitations. • Aeration: An important post· sterilization procedure to reduce residual

ethylene oxide and its by-products to a safe level. Mechanical aerators are available to accelerate the aeration process.

Ethylene Oxide Indicators • An ilropertant method of monitoring sterilization conditions. • Biological sterilization !~dicators: spore culture test recommended with each

load. . • Chemical sterilization indicators: provide a color change for immediate check

of al! four ethylene oxide sterI'izing parameters in each package. ;;, • Chemical process indicators: provide a color change when exposed to ethY~

oxide gas. " •

BIBLIOGRAPHY 1) Joint Commission on Accreditation 01 Hospitals, Accreditation Manual for Hospitals 1985. 2 ) Per1dns, J.J., Principles and Methods of Sterilization in Health Sciences, 2nd ed. C.T. Thomas 1969. 3) OSHA Regulations (Federal Register) 4 ) AORN Recommended Practice for Inhospital Sterilization, Association of Operating Room Nurses, 1980. 5 ) Central Service Technical Manual, William H. L. Dornette, M.D., J.D. Editor, (2nd ed.)

GLOSSARY , AMpllc: Free from living microorganisms.

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STERILIZING GAS a COMPRESSED GAS

n.o.s. UN 1956

Active Ingredient Ethylene Oxide ........... 1 2%

Inert Ingredients ............ 88% Total 100%

EPA EST. NO. D 35084-NJ-,

D 35084-MO-,

D 35084-TN-'

D 35084-TX-'

D 35084-CA-' D 35084-PA-2

D 35084-GA-' D 36736-NY-o,

TOTAL CONTENTS ___ LBS. NET

Precautionary Statements Hazards to Humans and Domesllc Animals

DANGER Extremely hazardous liquid and gas under pressure. Inhalation of gas may be fatal. 00 not get in eyes. on skin. or on clothing. Ethylene Oxide is odorless. Exposure to toxic levels may occur without warning or detection by the user. Physical or Chemical Hazards DANGER: liquid and gas under pressure. Use equipment rated tor cylinder pressure. Store and use with ade­quate ventilation. Close valve aller each use and when empty. Always replace cylinder cap when not in use. Cylinder temperature should not exceed 130·F (54· C). Use in accordance with the sterilizer manufacturers operating instructions. HEALTH HAZARDS: Inhalation may result in delayed nausea, narcotic and possible neurotoxic effects which could lead to emphysema, bronchitis and pulmonary edema. Exposure to large concentrations causes rapid circulatory insufficiency leading to coma and death. Contact with rapidly evaporating liquids may cause frostbite or cryogenic burns. fiRST AID: If inhaled, remove to fresh air.lfnot breathing, give artifiCial respiration. preferable mouth-to-mouth. If breathing is difficul:, give Oxygen. CALL A PHYSICIAN IMMEDIATELY and advise him of the exposure to this gas mixture. In case of eye (II skin contacl. or frostbite, remove contaminated clothing and flush affected are. with lukewarm water. 00 NOT USE HOT WATER.

KEEP our OF REACH OFClDLDREN

DANGER Sbfftnmt 01 PncdcaI Ti t4 ,N

In ali cases of overexposure, get medical allentoon Immediattly Take person to a doctor or emergency treatment facihty. Ifinhaled:Gel exposed person 10 fresh air Keep warm Make sure person can breathe freely. If breathIng has stopped, give artificial respiration, preferably mouth­to-mouth Do not give anythrng by mouth to an unconscious person II on akin: ImmedIately remove contamInated clothIng. shoes. and other items covellng skrn Wash contam­rnated skin area thoroug".ly with soap and water II In eyea: Hold eyehds open and flush WIth a steady. gentle stream of waler for at least t5 minutes

Manufaclured by:

DANGER CONTAINS ETIlYLENE OXIDE AVOID BREATInNG THIS GAS

Directions for Use It is a violation of Federal Law to use this produ.;t in a manner inconsistent with its label/inll. The product is limited to use by medical profess:cr.a~~ or trained technical personnel in medical ~nd industrial use areas.

STORAGE AND DISPOSAL Store in cool. well-ventilated area Avoid exposure to heat or direct sunlight When empty. return to manufacturer only.

ARC CHEMICAL Div. of Balchem l·~·p P.O. Box 180 \

Slate Hill. NY 10973